Journal of Clinical Medicine (Jul 2022)
Effectiveness of Golimumab as Second Anti-TNFα Drug in Patients with Rheumatoid Arthritis, Psoriatic Arthritis and Axial Spondyloarthritis in Italy: GO-BEYOND, a Prospective Real-World Observational Study
- Salvatore D’Angelo,
- Enrico Tirri,
- Angela Maria Giardino,
- Marco Mattucci-Cerinic,
- Lorenzo Dagna,
- Leonardo Santo,
- Francesco Ciccia,
- Bruno Frediani,
- Marcello Govoni,
- Francesca Bobbio Pallavicini,
- Rosa Daniela Grembiale,
- Andrea Delle Sedie,
- Rita Mulè,
- Francesco Paolo Cantatore,
- Rosario Foti,
- Elisa Gremese,
- Paola Conigliaro,
- Fausto Salaffi,
- Ombretta Viapiana,
- Alberto Cauli,
- Roberto Giacomelli,
- Luisa Arcarese,
- Giuliana Guggino,
- Romualdo Russo,
- Amy Puenpatom,
- Domenico Capocotta,
- Francesca Nacci,
- Maria Grazia Anelli,
- Valentina Picerno,
- Corrado Binetti,
- Florenzo Iannone
Affiliations
- Salvatore D’Angelo
- Istituto Reumatologico Lucano (I.Re.L), Dipartimento Regionale di Reumatologia, AOR San Carlo di Potenza, 85100 Potenza, Italy
- Enrico Tirri
- UOSD di Reumatologia, Ospedale San Giovanni Bosco, 80144 Napoli, Italy
- Angela Maria Giardino
- Medical Affairs MSD Italia S.r.l., 00189 Rome, Italy
- Marco Mattucci-Cerinic
- A.O. Careggi Università, 50134 Firenze, Italy
- Lorenzo Dagna
- Unit of Immunology, Rheumatology, Allergy and Rare Diseases (UnIRAR), IRCCS San Raffaele Scientific Institute, Vita-Salute San Raffaele University, 20132 Milan, Italy
- Leonardo Santo
- U.O.S. Reumatologia ASL BT—DSS 4, 76121 Barletta, Italy
- Francesco Ciccia
- AOU Università degli Studi della Campania “Luigi Vanvitelli”, 80138 Napoli, Italy
- Bruno Frediani
- UOC di Reumatologia, Azienda Ospedaliero Universitaria Senese, 53100 Siena, Italy
- Marcello Govoni
- AOU S. Anna di Ferrara, UOC Reumatologia, Dipartimento di Scienze Mediche, Università di Ferrara, 44121 Ferrara, Italy
- Francesca Bobbio Pallavicini
- Fondazione IRCCS Policlinico San Matteo S.C. Reumatologia, 27100 Pavia, Italy
- Rosa Daniela Grembiale
- Rheumatology Research Unit, Dipartimento di Scienze della Salute, Università degli studi “Magna Graecia” di Catanzaro, 88100 Catanzaro, Italy
- Andrea Delle Sedie
- U.O. Reumatologia Azienda Ospedaliero Universitaria Pisana, 56126 Pisa, Italy
- Rita Mulè
- IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant’Orsola, UO Reumatologia, 40138 Bologna, Italy
- Francesco Paolo Cantatore
- UOC Reumatologia Universitaria, “Ospedali Riuniti” di Foggia, 71122 Foggia, Italy
- Rosario Foti
- A.O.U. Policlinico G. Rodolico-S. Marco, U.O di Reumatologia, 95123 Catania, Italy
- Elisa Gremese
- Fondazione Policlinico Universitario A. Gemelli-IRCCS, Università Cattolica del Sacro Cuore, 00168 Rome, Italy
- Paola Conigliaro
- UOC Reumatologia, Dipartimento di Medicina dei Sistemi, Università di Roma “Tor Vergata”, 00133 Rome, Italy
- Fausto Salaffi
- Clinica Reumatologica, Ospedale “C. Urbani” Università Politecnica delle Marche, 60035 Ancona, Italy
- Ombretta Viapiana
- Ospedale Borgo Roma Policlinico G.B. Rossi, U.O.C. Reumatologia, 37126 Verona, Italy
- Alberto Cauli
- Azienda Osped/Universitaria Policlinico Monserrato, 09124 Cagliari, Italy
- Roberto Giacomelli
- UOC ImmunoReumatologia, Università CampusBio Medico di Roma, 00128 Rome, Italy
- Luisa Arcarese
- UOC ImmunoReumatologia, Università CampusBio Medico di Roma, 00128 Rome, Italy
- Giuliana Guggino
- PROMISE Department, University of Palermo, 90133 Palermo, Italy
- Romualdo Russo
- AORN, A. Cardarelli U.O.S. Reumatologia, 80131 Napoli, Italy
- Amy Puenpatom
- Center for Observational and Real-World Evidence, Merck & Co., Inc., Kenilworth, NJ 07033, USA
- Domenico Capocotta
- UOSD di Reumatologia, Ospedale San Giovanni Bosco, 80144 Napoli, Italy
- Francesca Nacci
- Department of Experimental and Clinical Medicine, Divisions of Rheumatology AOUC, University of Florence, 50134 Florence, Italy
- Maria Grazia Anelli
- Rheumatology Unit, DETO, University of Bari, 70124 Bari, Italy
- Valentina Picerno
- Istituto Reumatologico Lucano (I.Re.L), Dipartimento Regionale di Reumatologia, AOR San Carlo di Potenza, 85100 Potenza, Italy
- Corrado Binetti
- Medical Affairs MSD Italia S.r.l., 00189 Rome, Italy
- Florenzo Iannone
- Rheumatology Unit, DETO, University of Bari, 70124 Bari, Italy
- DOI
- https://doi.org/10.3390/jcm11144178
- Journal volume & issue
-
Vol. 11,
no. 14
p. 4178
Abstract
In this prospective observational study, data were collected from 34 rheumatology clinics in Italy in patients with rheumatoid arthritis (RA), psoriatic arthritis (PsA) and axial spondyloarthritis (axSpA) who started golimumab (GLM) as a second anti-TNFα drug. The primary objective was to evaluate the effectiveness of GLM after 6 months. Changes in quality of life using the EQ-5D-5L were also assessed. A total of 194 patients aged 53.2 ± 12 years started GLM as a second anti-TNF drug: 39 (20.1%) with RA, 91 (46.9%) with PsA and 64 (32.9%) with axSpA. After 6 months of GLM treatment, 68% of RA patients achieved low disease activity (LDA; DAS28-CRP ≤ 3.2), 31.9% of PsA patients achieved minimal disease activity and 32.5% of axSpA patients achieved LDA (ASDAS-CRP < 2.1). Good/moderate EULAR response was achieved in 61.9% and 73.8% of patients with RA and PsA, respectively, and 16% of axSpA patients achieved a 50% improvement in BASDAI. Across all indications, improvements in disease activity measures and EQ-5D-5L domains were observed over 6 months. The main reasons for GLM interruption were lack/loss of efficacy (7.2%) or adverse events (2%). This study confirms the effectiveness of GLM as a second-line anti-TNF for the treatment of RA, PsA and axSpA in a real-world setting in Italy.
Keywords
- golimumab
- anti-TNF inhibitor
- biologic
- rheumatoid arthritis
- psoriatic arthritis
- axial spondyloarthritis